A trial looking at surgery or different types of radiotherapy for rectal cancer (STAR-TREC)

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Cancer type:

Bowel (colorectal) cancer
Rectal cancer

Status:

Open

Phase:

Phase 2/3

This trial is for people with early stage cancer of the back passage (rectum). The stage of a cancer tells you how big it is and how far it’s spread. It helps your doctor decide which treatment you need. 

People in this trial have T1 to T3b (T stage) rectal cancer.

Cancer Research UK supports this trial. 

More about this trial

Surgery is the usual treatment for early stage rectal cancer. Your surgeon removes the rectum and sometimes the anus Open a glossary item. This is the standard treatment Open a glossary item.
 
But surgery can cause side effects such as problems controlling your bowels and leakage of poo (stools) and urine. 
 
In this trial, doctors want to find out if either: 

is as good as the standard treatment at curing early stage rectal cancer. And whether they cause less side effects. This is called organ saving treatment.

This trial is in 2 parts. In part 1 researchers wanted to see if enough people with early stage rectal cancer are willing to take part in this type of clinical trial. They also wanted to learn more about organ saving treatment, particularly about the side effects and how people feel after treatment. This part of the trial is now closed.

In part 2 doctors want to find out which organ saving treatment is better at curing early stage rectal cancer. Everyone joining part 2 can choose between:

  • surgery (standard treatment)
  • organ saving treatment

People who choose organ saving treatment are put into one of the following treatments: 

  • high dose radiotherapy for 5 days (short course radiotherapy)
  • chemotherapy and low dose of radiotherapy for 5 weeks (long course of chemoradiotherapy)

Please note - Doctors are currently looking for people to join part 2. 

People who have short course radiotherapy or long course of chemoradiotherapy may also have a small operation (a trans anal microsurgery) afterwards if there is any cancer remaining. 

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

You may be able to join this trial if all of the following apply:

  • You have an early stage adenocarcinoma of the rectum (T1, T2, T3a or T3b)
  • Doctors think that surgery, radiotherapy or chemoradiotherapy are all suitable treatments for you  
  • You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You are at least 16 years old

If you choose to have organ saving treatment, you must be willing to use reliable contraception during treatment and for 6 months afterwards if there is any possibility that you or your partner could become pregnant. 

You cannot join this trial if any of these apply: 

Cancer related

  • Your cancer has spread to other parts of the body, the lymph nodes  Open a glossary itemor the blood vessels Open a glossary item around it    
  • You have a type of cancer called mucinous tumour Open a glossary item
  • Your cancer measures more than 40 mm across or is very close to a sheet of tissue called mesorectal fascia (your doctor can tell you about this) 
  • Your cancer is above an area called peritoneal reflection (your doctor will know if this applies to you)
  • You have had a small operation to remove the cancer called an endoscopic resection and there is no cancer left  
  • You can’t have radiotherapy for any reason 
  • You have or have had another cancer in the last 3 years, unless your doctor thinks it is stable and won’t cause you any problems for the next 3 years

Medical conditions

  • You have heart problems such as angina that isn’t controlled, an abnormal heart rhythm or you have had a heart attack in the last 6 months 
  • You have low levels (a deficiency) of an enzyme called dihydropyrimidine dehydrogenase (DPYD)
  • You have high levels of bilirubin (Gilberts disease)
  • You take warfarin or any other similar drug and you can’t stop it for at least 7 days before the start of treatment
  • You take metronidazole
  • You have taken phenytoin, sorivudine or any other similar drugs in the last month 
  • You are sensitive to a group of chemotherapy drugs called fluoropyrimidine Open a glossary item

Other

  • You are pregnant or breastfeeding

Trial design

This is an international phase 2/3 trial. Researchers need up to 500 people worldwide to take part. 

This trial is in 2 parts. Doctors are currently looking for 380 people to join part 2.

Everyone taking part can choose between:

•    surgery (standard treatment)
•    organ saving treatment

 
Surgery
You have surgery to remove the rectum. You can have either:

  • a large cut in the tummy (abdomen) 
  • a number of small cuts in the tummy (keyhole surgery)

After your rectum has been removed your large bowel (colon) is reconnected to your anus. You may also have the anus removed if the cancer is very close to it. If this happens your surgeon stitches the end of the large bowel to a hole cut in the skin of your abdomen (a colostomy). 

You usually stay in hospital for about 4 to 10 days. This depends on the type of operation you have. 

Organ saving treatment 
Everyone having the organ saving treatment is put into 1 of the following groups at random:

  • high dose radiotherapy for 5 days (short course radiotherapy)
  • chemotherapy and low dose of radiotherapy for 5 weeks (long course of chemoradiotherapy)

Neither you nor your doctor can choose which group you are in. This is called randomisation. 

Short course radiotherapy
You have a high dose of radiotherapy every day, for 5 days (Monday to Friday). 

After about 3 months you have a test using a flexible tube with a camera and a light at one end to look at the rectum (an endoscopy) and an MRI scan. Then if:

  • your cancer has stayed the same (poor response) you have surgery to remove the rectum
  • your cancer has got better (good response) you have a second endoscopy and MRI after 1 or 2 months 

After the 2nd endoscopy and MRI, if there is no signs of the cancer and your bowel looks normal, you have regular follow up. But if doctors think a few cancer cells may have been left behind, you have a small operation (trans anal microsurgery) to remove the part of the bowel where the cancer is.  
  
Long course of chemoradiotherapy 
You have radiotherapy every weekday (Monday to Friday), for 5 weeks. It takes about 15 minutes each time. 

You also take the chemotherapy drug capecitabine. You have it twice a day, on the same days you have radiotherapy. 

After about 3 months you have an endoscopy to look at the rectum and an MRI scan. Then if:

  • your cancer stayed the same you have surgery to remove your rectum
  • your cancer got better, you have a second endoscopy and MRI after 1 or 2 months

After the 2nd endoscopy and MRI, if there is no signs of the cancer and your bowel looks normal, you have regular follow up. But if doctors think a few cancer cells may have been left behind, you have a small operation (trans anal microsurgery) to remove the part of the bowel where the cancer is.  

Quality of life 
Everyone taking part completes a quality of life questionnaire before the start of treatment and then after:

  • 3 months
  • 12 months
  • 2 years
  • 3 years 

The questionnaire asks about how you have been feeling and what side effects you have had. 

Endoscopy and MRI scan
You have extra tests to check that the treatment is working and to look for signs of the cancer coming back. 

You have: 

  • an MRI scan before the start of treatment and at set times after treatment
  • an endoscopy to look at your rectum and bowel at set times after treatment 

Your doctor can tell you how often you have the extra endoscopies and MRI scans.

Tissues samples 
The trial team asks to use a tissue sample of your cancer taken:

  • when you were diagnosed (stored biopsy)
  • during surgery (if you have this) 

They want to look at the DNA Open a glossary item and other chemicals that can help to tell why treatments work better for some people than others.  

Blood tests
You have an extra blood test before starting treatment. Researchers want to look for certain proteins that can tell why treatments work better for some people than others.

Hospital visits

You see a doctor and have some tests before taking part. These tests might include: 

  • blood tests
  • urine test
  • a physical examination 
  • a test to look at the inside of the bowel (colonoscopy
  • a CT scan and MRI scan 
  • an ultrasound scan of the rectum 

After radiotherapy or chemoradiotherapy you see the trial team every 3 months for a year. After a year, you see them every 6 months for the next 3 years. Your doctor can tell you for how long you will see them. 

You also have a CT scan after 2 years.

If you have the standard treatment (surgery) you see the trial team after a month and then at regular intervals for up to 3 years. You also have a CT scan after 2 years. 

Side effects

The trial team monitor you during the time you have treatment and you have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.

Radiotherapy to the rectum has short term (or acute) side effects that usually start a few days after the radiotherapy begins. And side effects that can start some months or years later (long term or late side effects).  

The short term side effects of radiotherapy include:

  • sore skin and pain in your tummy (abdomen) 
  • diarrhoea
  • passing urine more often (frequency)
  • tiredness (fatigue)
  • feeling or being sick
  • lack of fluids in your body (dehydration) Open a glossary item
  • lack of interest in sex 

We have more information about short term side effects of radiotherapy.

And information about:

Location

Birmingham
Bradford
Bristol
Cambridge
Cardiff
Colchester
Dundee
Leeds
Manchester
Norwich
Oxford
York

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Mr Simon Bach

Supported by

Cancer Research UK 
University of Birmingham

Other information

This is Cancer Research UK trial number CRUK/14/033

 

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14493

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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